Glabellar Frown Lines Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
| Verified date | April 2018 |
| Source | Huons Co.,Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
| Status | Active, not recruiting |
| Enrollment | 260 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | October 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely Exclusion Criteria: - Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.) - From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks - Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc - Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day) - Any condition that, in the view of the investigator, would interfere with study participation |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Huons | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Huons Co.,Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FWS(Facial Wrinkle Severity) Improvement at glabellar line | Change from Baseline of Glabellar Lines improvement rate(Frown) | 4 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02236312 -
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
|
Phase 2 | |
| Active, not recruiting |
NCT05565950 -
AI-09 In Subjects With Glabellar Lines, GL-101
|
Phase 1/Phase 2 | |
| Completed |
NCT00430963 -
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
|
Phase 3 | |
| Recruiting |
NCT05083286 -
Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines
|
Early Phase 1 | |
| Completed |
NCT03687736 -
Subject Satisfaction With AbobutulinumtoxinA Treatment
|
Phase 4 | |
| Active, not recruiting |
NCT04281745 -
Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®
|
Phase 4 | |
| Active, not recruiting |
NCT05623410 -
Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines
|
Phase 3 | |
| Completed |
NCT03736928 -
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
|
Phase 2 | |
| Completed |
NCT01808742 -
Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device
|
N/A | |
| Completed |
NCT00777803 -
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
|
Phase 3 | |
| Completed |
NCT00430586 -
Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
|
Phase 2 | |
| Completed |
NCT04281095 -
A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05146999 -
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines
|
Phase 3 | |
| Completed |
NCT02428608 -
Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006
|
Phase 2 | |
| Completed |
NCT04143815 -
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines
|
Phase 2 | |
| Not yet recruiting |
NCT05305768 -
Xeomin Treatment of Glabellar Lines Using OLD Versus COLD
|
Early Phase 1 | |
| Completed |
NCT05364580 -
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
|
Phase 3 | |
| Completed |
NCT05320393 -
Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines
|
Phase 2 | |
| Completed |
NCT02677805 -
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II
|
Phase 3 | |
| Not yet recruiting |
NCT05894109 -
Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids
|
N/A |